Recall Z-1546-2015 ยท HSB Rod, Fixation, Intramedullary And Accessories
Pega Medical Inc.
Female Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval IM Telescopic System. For orthopedic procedures. This instrument is included in the Fassier-Duval IM Telescopic System instrument tray. This instrument is marked with the catalogue number and lot number.
| Date | Apr 29, 2015 (initiated Apr 10, 2015) |
| Status | Terminated |
| Reason | The hexagonal tip of the Female Driver instrument for the Fassier-Duval IM Telescopic System is 0.06 mm under the specifications. This may result in a reduction of the total strength of the instrument, possibly leading to deformation, wear, and tip breakage. |
| Root cause | Nonconforming Material/Component |
| Action | The firm sent the Urgent Field Safety Notice-Recall letter, dated April 10, 2015 to consignees via email. The letter listed the affected product as FEMALE DRIVER FASSIER-DUVAL IM TELESCOPIC SYSTEM. Consignees are requested to return devices back to the firm for disposal. Consignees with questions should contact the firm at 450-688-5144 ext. 242 or send email to egarcia@pegamedical.com |
| Quantity | 9 units (5 units in the US and 4 units international) |
| Distribution | Worldwide distribution. US in Delaware, Florida, Nebraska, and New York; Australia, Brazil, and United Kingdom. |
| FDA record | Open on fda.gov |